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    Originally posted by Jim View Post
    you are in the ballpark...
    Anything less cryptic?

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      Originally posted by rukiddingme View Post
      I don't think I'm jumping to conclusions after reading many of your posts. You did mention that you were working on something in your lab regards to high injuries (neuron replacement) which would be needed for cervical SCI. Just injecting UCBC + Lithium is a far reach for high injuries, thats why only 25% of such a small number were cervical SCI in those trials. The reason for 25% of those 20 subjects, was to see if you could get a few nerves to activate the walking generator. When will you be analyzing this little percentage group for limb function? Will there be any trials in the pipeline that will concentrate on arm/hand function in the distant future? Enquiring Quads want to know.....
      rukiddingme,

      The number of cervical spinal cord injuries in the Kunming study is simply because more people with thoracic spinal cord injuries volunteered for this study than cervical. Only 5 subjects in the trial had cervical spinal cord injuries. In the phase III trial, there will be more subjects and we should be able to tell whether this treatment has an effect on cervical spinal cord injuries or not.

      Wise.

      Comment


        Dr. Young,

        Are any groups in the acute / subacute UCB trial receiving 6 months of intensive rehab like those in the chronic trial? Thank you.

        Comment


          Originally posted by NowhereMan View Post
          Dr. Young,

          Are any groups in the acute / subacute UCB trial receiving 6 months of intensive rehab like those in the chronic trial? Thank you.
          Thirteen subjects with subacute spinal cord injury received the UCBMC transplants and then 3-6 months of locomotor training. Included in this trial are another 13 subjects who received surgery only and no cell transplants. This study is still double-blinded and therefore we have not looked at the data yet.

          Wise.

          Comment


            Wise - You talked about patients being able to walk with CGP without any functional movement laying down. Would these same patients be able to pedal a bicycle or is walking the only movement they can do?
            c6 inc since 2-19-11
            ex pro-am motocross racer
            tilite aero z s2

            Comment


              Dr. Young,
              I have a question I'd really like your viewpoint on, and it's not meant with any shred of an attempt to antagonize, sincerely. But if the phase III trials show no more and no less of an indication of recovery for the patients (75% of patients recover minimally assisted but non-functional therapeutic stepping, no significant change in sensation, b/b/s or motor function) could you provide your thinking as to the cost-benefit of pushing this through phase III, trying to have doctors agree to do the surgery and cell injection, have patients go through months of rehabilitation, and have insurance companies actually cover this?
              I know severe chronic SCI has no other therapies, I know the idea of regaining ANY form of walking is really exciting to all of us and I suspect many of us feel we could "do better" if we just were able to start activating the CPG.
              But the other side of me also knows that there is no reason to anticipate any further or stronger recovery until its been demonstrated in the trial. So if recovery levels out at what you've seen so far, could you tell me why you think it's worth the 30 million needed for the trial, the tour-de-force you mentioned for the doctors hesitant to apply the therapy, and the millions (billions?) more dollars and months and months of grueling rehab needed once every SCI starts demanding this therapy, the subsequent rehab, etc.
              Again, this question is a sincere one and I'm sure you have some thoughts (better informed than I) on the balance between waiting for the most efficacious therapies and getting SOMETHING (albeit imperfect) to the community. Thanks.

              Comment


                Originally posted by void
                Thank you for a very good response!

                Of course, but then shouldn't the patient experience scores close to the lesion site? As they are T injurys shouldn't there by now be an increase in motor scores in the trunk, since these would have a short distance to grow. I don't know the amount of locomotor training the patients performed considering the trunk though.
                Many of our subjects have improvements in their sensory scores in the thoracic segments. By the way, we don't collect data concerning motor function of the thoracic segments (trunk and abdomenal muscles) because the examination is too hard to do without instrumentation and the ASIA examination omitted these muscles. In order to walk like they do (walk hundreds of meters using a rolling walking frame with minimal assistance with a rope around the knees to assist in the stance phase so that the knees don't buckle), many of our subjects had to make significant improvements in their truncal and postural muscles. So, we suspect that they have improved their trunk motor performance but we have only sensory scores for the trunk. Note that about 25% of the patients in the Kunming study had cervical spinal cord injury and they seemed to have regained as much locomotor function as the thoracic cases.

                Wise.

                Comment


                  Dr. Young,
                  Are there any restrictions or limitations in Phase III for length of post-injury time? I read where 13 years was the longest time of injury in Phase II but was wondering if you would try to find older injuries for Phase III, or does Phase II pretty well confirm age of injury doesn't seem to be an issue?
                  Thank you.

                  Comment


                    Professor what is the difference between cells from the umbilical cord you use in your clinical trial
                    and the cell of BIOE of umbilical cord mlpc lien http://www.bioe.com/Product/Product....18&prodNav=pur
                    I thank you in advance for your answer

                    Comment


                      Dr.Young How happy are the patients who took part in your Kumming trials? I hope they are very,very happy, but what I mean by my question is :Over all. Do the patients seem pleased with the results vesres the amount of work they had to put in to achive those results? (was the squeeze worth the juice?) I'm sure all are glade they did it, I just wonder if it was harder than they expected. How do you feel knowing that you were able to make it possible

                      Comment


                        kickingber,

                        I met most of the patients mid-way in the trial. At the time, I don't think that many of them were expecting all that much. Many told me that they were getting this or that function back. Most of course knew that they were getting better walking back because they were walking and had worked hard to achieve that recovery. Of course, they were happy about that. I don't know whether they are attributing it to the treatment or to their hard work. I didn't see most of the patients towards the end of the trial.

                        It was the family members that expressed the strongest positive feelings. Several of them were crying (with happiness). I don't know what the difference of expectation were between the family members and patients. Perhaps some of the patients thought that they were supposed to get such recovery back if they really worked hard at it. It is interesting that a number of them went back home for 6 months and did little or no walking, and lost their ability to walk. However, if they came back to the hospital, they regained the walking only after a relatively short period of practice.

                        Wise.

                        Comment


                          Thanks for posting that Doc. Its pretty uplifting to read. Anyways, have you heard anything about bowel, bladder, and sexual function in these patients? If not, do you plan to see what they are experiencing, if anything, in those areas? Thanks.

                          Comment


                            Dr. Young when do you expect these results to the publish and release?

                            Comment


                              " I pointed out that injuries to the lower thoracolumbar cord may not benefit from cord blood cells transplants as much and that we will need neuronal replacement therapies for people with flaccid paralysis of the legs."

                              1)Do these therapies exist?

                              2) Are these trials are c5-c7 chronic sci only?
                              Han: "We are all ready to win, just as we are born knowing only life. It is defeat that you must learn to prepare for"

                              Comment


                                Originally posted by jhope
                                Yesterday, 09:30 PM

                                " I pointed out that injuries to the lower thoracolumbar cord may not benefit from cord blood cells transplants as much and that we will need neuronal replacement therapies for people with flaccid paralysis of the legs."

                                1)Do these therapies exist?

                                2) Are these trials are c5-c7 chronic sci only?


                                (1) Yes, neuronal replacement therapies do exist and the reason why so many scientists are interested in neural stem cell therapy. Neural stem cells should be able to produce neurons to replace neurons that have been lost. NeuralStem Inc. and Stem Cell, Inc. both have neural stem cell lines (from fetal sources) but they assume that the cells will not be immunologically rejected after transplantation and the treatments may require immune-suppression. We have been working on two potential sources of immune-matched neural stem cells. The first is Muse cells from HLA-matched umbilical cord blood. Muse cells are pluripotent cells that have been reported to produce neurons. We have found that umbilical cord blood contains large numbers of such Muse cells. We are trying now to grow these cells. Muse cells would not require genetic manipulation. The second are bone marrow cells. Bone marrow has muse cells and it would be possible to remove bone marrow cells from the patient, extract Muse cells, differentiate them to neurons, and then transplant them into the patient without genetic manipulation. We are doing these studies now in the laboratory.

                                (2) Which trials are you referring to when you say "these trials"? If you are referring to Phase III trial that we are planning for next year, the trials will be from people from C5 to T11 neurological levels. If you are referring to trials that we hope to start for thoracolumbar injuries, I don't think that we will be ready to start them until 2015 at the earliest and probably not until 2016. There are many problems that still have to be solved before we can take Muse cells to trial.

                                Wise.




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